Wearable defibrillator with audio input/output

ABSTRACT

A wearable device and method of monitoring the condition of a patient. The wearable device includes at least one sensor and at least one processor operatively connected to the at least one sensor. The wearable device also includes an operator interface device operatively connected to the at least one processor. The at least one processor causes the device to allow for customization of at least one output message to be delivered via the operator interface device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/325,041 titled “Wearable Defibrillator with Audio Input/Output” filedon Jul. 7, 2014, which is a division of U.S. application Ser. No.13/757,105 titled “Wearable Defibrillator with Audio Input/Output” filedon Feb. 1, 2013, now U.S. Pat. No. 8,774,917, which is a continuation ofU.S. application Ser. No. 12/082,168 titled “Wearable Defibrillator withAudio Input/Output” filed Apr. 9, 2008, now U.S. Pat. No. 8,369,944,which claims priority under 35 U.S.C. §119(e) to U.S. Provisional PatentApplication Ser. No. 60/933,310 filed on Jun. 6, 2007, each of which ishereby incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

This invention relates to wearable defibrillators.

BACKGROUND

There are many patients susceptible to heart arrhythmias who are at risksudden death. For example, patients undergoing a coronary arteryocclusion and myocardial infarction are at substantial risk oftachyarrhythmia for several weeks following the coronary arteryocclusion. Such patients are generally hospitalized but can bedischarged earlier if there is a practical means to protect them fromlife threatening arrhythmias. One such practical means includes theimplantation of an automatic defibrillator. However, patients may alsobe discharged prior to such an implantation if an externaldefibrillator, such as, for example, a wearable defibrillator, isavailable in case they experience a life-threatening tachyarrhythmia.

There are also patients who are placed at an inordinate risk due to thesurgery required for implanting an implantable defibrillator. For suchpatients, implantation would preferably be avoided so such an inordinaterisk could be avoided or otherwise mitigated.

Wearable defibrillators are often used to help people who have anincreased risk of experiencing a life threatening arrhythmia due tospecific heart conditions. Such wearable defibrillators are typicallyconfigured to provide treatment if a life threatening arrhythmia isdetected. For example, U.S. Pat. Nos. 4,928,690, 5,078,134, 5,741,306,5,944,669, 6,065,154, 6,097,987, 6,253,099, 6,280,461 and 6,681,003,disclose wearable defibrillators. The entirety of U.S. Pat. Nos.4,928,690, 5,078,134, 5,741,306, 5,944,669, 6,065,154, 6,097,987,6,253,099, 6,280,461 and 6,681,003, are hereby incorporated herein byreference.

Wearable defibrillators are typically used to help patients that eithercannot risk an implantation of a defibrillator or are awaiting such animplantation. Occasionally, analysis performed by the wearabledefibrillator may falsely indicate that the patient is experiencing anarrhythmia that requires treatment. In such circumstances, the wearabledefibrillator generates an audible alarm that is configured to stop if apatient provides a required response, such as, for example, pressing oneor more response buttons. If a patient fails to press such buttons orotherwise provide a required response, the device may assume the patientis unconscious and is experiencing a condition requiring treatment.Occasionally, a bystander who is unfamiliar with a wearabledefibrillator may interfere with the device by intentionally pressingthe response buttons or otherwise providing a response which delays orinhibits patient treatment.

The present invention is directed toward overcoming one or more of theabove-mentioned problems.

SUMMARY

A wearable defibrillator is provided that includes one or more therapypads one or more sensors, one or more processing units operativelyconnected to the one or more therapy pads and one or more sensors andone or more audio devices operatively connected to the one or moreprocessing units. The one or more audio devices are configured toreceive audio input from a patient.

One embodiment of the wearable defibrillator may include one or moreaudio devices that are one or more microphones, one or more speakers ora combination of one or more speakers and one or more microphones.Another embodiment of the wearable defibrillator may include one or moreprocessing units that include one or more processors and at least onememory connected to the one or more processors.

In another embodiment of the wearable defibrillator, the one or moreprocessing units can be configured to record the patient name using amicrophone and store the audio recording in non volatile memory. In someembodiments of the wearable defibrillator, a recording of the patient'sname made during setup by either an operator or patient can be playedback during startup to uniquely identify who the wearable defibrillatorbelongs to.

In some embodiments of the wearable defibrillator, the one or moreprocessing units can be configured to cause at least one patientresponsiveness test to be run upon detection of an arrhythmia conditionby the one or more sensors. In one embodiment, one of the one or moreresponsiveness tests can include at least one voice recognitionresponsiveness test, at least one button responsiveness test, or anycombination thereof. For example, the one or more processing units canbe configured to cause a response button responsiveness test to be runonly after a voice recognition responsiveness test resulted in aresponse that indicated the patient is not conscious. Of course, otherembodiments of the wearable defibrillator may include one or moreprocessing units that are configured to run other patient responsivenesstests or sequences of such patient responsiveness tests.

In one embodiment of the wearable defibrillator, the audio input caninclude one or more sounds, such as, for example, at least one spokenword, made by the patient and the one or more processing units can beconfigured to recognize the audio input from the patient. In someembodiments of the wearable defibrillator, the one or more processingunits may be configured such that the wearable defibrillator eitherdelays or does not provide a treatment to the patient when the one ormore sounds is received by the one or more audio devices and recognizedby the one or more processing units.

In another embodiment of the wearable defibrillator, the wearabledefibrillator may include one or more processing units that areconfigured to recognize audio input provided by a base unit configuredto operatively connect to the wearable defibrillator to verify that thebase unit is functioning properly. In some embodiments of the wearabledefibrillator, the base unit can include a modem and the audio inputprovided by the base unit can include sound made by the modem. In yetanother embodiment of the wearable defibrillator, the wearabledefibrillator can include one or more mechanisms connected to the one ormore processing units and the one or more processing units areconfigured to recognize input provided by the one or more mechanisms toverify that the one or more mechanisms are operating correctly. In someembodiments of the wearable defibrillator, the one or more mechanismscan include relays, switches or any combination thereof that produce anaudible sound upon activation or deactivation.

In one embodiment of the wearable defibrillator, the processing unit ofa wearable defibrillator can be configured to cause an alarm to beemitted to verify that the wearable defibrillator can properly emit thealarm. In another embodiment, the one or more processing units can beconfigured to cause one or more speakers to produce audio output and beconfigured to adjust at least one of the frequency and the amplitudecharacteristics of the audio output based upon audio input received fromone or more microphones.

In some embodiments of the wearable defibrillator, the one or moreprocessing units can be configured to cause data obtained by the one ormore sensors to be recorded in memory connected to the one or moreprocessing units. In one embodiment of the wearable defibrillator, theaudio input can include a command and the one or more processing unitscan be configured to cause data obtained by the one or more sensors tobe recorded in at least one memory after the command is received by theone or more audio devices.

In one embodiment of the wearable defibrillator, the one or moreprocessing units can be configured to cause a self-diagnostic test to berun if the audio input includes a high amplitude and short durationnoise that may be indicative of device abuse.

A system configured to monitor a patient is also provided. The systemincludes a central location, and a wearable defibrillator configured tooperatively connect to the central location. The wearable defibrillatorincludes one or more therapy pads, one or more sensors, one or moreprocessing units operatively connected to the one or more therapy padsand one or more sensors and one or more audio devices operativelyconnected to the one or more processing units. The one or more audiodevices are configured to receive audio input from a patient.

In some embodiments, the system may further include a base stationconfigured to operatively connect the wearable defibrillator to thecentral location. In other embodiments, the one or more processing unitsof the wearable defibrillator may include at least one communicationdevice configured to connect the wearable defibrillator to the centrallocation. Preferably, the one or more communication devices include amodem, a network card, one or more networking programs, other networkingmechanisms or any combination thereof.

In one embodiment of the system, the one or more audio devices can be amicrophone. In another embodiment of the system, the base station can beconfigured to communicate with the central location and the wearabledefibrillator may be configured to transmit data from the wearabledefibrillator to the central location. In yet another embodiment of thesystem, the central location can include one or more memory and beconfigured to store data transmitted from the wearable defibrillator inthe one or more memory.

A method of providing treatment to a patient is also provided. Themethod can include providing a wearable defibrillator to the patientthat includes one or more audio devices, monitoring the condition of thepatient, providing audio output from the one or more audio devices tothe patient to verify a monitored arrhythmia condition exists, receivingaudio input from the patient with the one or more audio devices andproviding treatment to the patient based on the audio input receivedfrom the patient. It should be appreciated that the audio input receivedfrom the patient may include silence or may include audible responses.

In some embodiments of the method of providing treatment to a patient,the method may also include recording the condition of the patient andcommunicating the recorded condition of the patient to a centrallocation. In other embodiments of the method, the method may includeutilizing one or more of the audio devices to conduct at least onediagnostic test of the wearable defibrillator, recording the resultsfrom the one or more diagnostic tests and evaluating the results of thetest or tests.

Other details, objects, and advantages of the invention will becomeapparent as the following description of certain present preferredembodiments thereof and certain present preferred methods of practicingthe same proceeds.

BRIEF DESCRIPTION OF THE DRAWINGS

Present preferred embodiments of the invention are shown in theaccompanying drawings and certain present preferred methods ofpracticing the same are also illustrated therein.

FIG. 1 is a schematic view of a first embodiment of the presentinvention, which illustrates an embodiment of a wearable defibrillator.

FIG. 2 is a block diagram of an embodiment of the present invention thatillustrates a system that includes an embodiment of a wearabledefibrillator configured to interact with a base station and a centrallocation.

DETAILED DESCRIPTION

Referring to FIG. 1, a wearable defibrillator may be worn by a patientand may include a belt or harness or other apparel configured to permitthe patient to wear the defibrillator. Sensors, such as electrodes 10 a,10 b, 10 c and 10 d are removably attached to the patient when thewearable defibrillator is worn by the patient. The electrodes 10 a, 10b, 10 c and 10 d form part of electrode assembly 11 and are operativelyconnected to a processing unit 15 via a trunk cable 13. In someembodiments, the processing unit 15 may include, without limitation, oneor more processors, one or more controllers and/or one or more programsor other software stored in memory operatively connected to one or moreprocessors.

The processing unit 15 is operatively connected to therapy pads 17, atleast one tactile stimulator 12, electrode assembly 11, and one or moreaudio devices 16. The audio devices 16 may include, for example, amicrophone and a speaker. The therapy pads 17 are removably connected tothe patient when the defibrillator is worn. The processing unit 15 mayinclude a visual read out and a speaker for communicating with thepatient or others around the patient.

A trunk cable 13 may be used to connect the electrode assembly 11 to theprocessing unit 15 and audio devices 16. Of course, other types ofcables or other connection devices used to operatively connect theelectrode assembly 11 to the processing unit 15, speakers, microphonesor other audio devices 16 may also be used. Wiring or other connectiondevices may also be used to connect at least one portion of theelectrode assembly 11 to the electrodes 10 a, 10 b, 10 c, and 10 d. Ofcourse, the processing unit 15 may alternatively be operativelyconnected to one or more of the electrodes 10 a, 10 b, 10 c, 10 d,therapy pads 17, electrode assembly 11, audio devices 16 and stimulator12 by a wireless connection or a combination of wireless and wiredconnections.

The audio devices 16 preferably include a Knowles Acoustics WP-23502microphone, a speaker and audio circuitry that include an audio CODECand an audio amplifier. The audio CODEC may contain an interpolationfilter and a noise shaper. An AC97 interface may be used to operativelyconnect the processing unit 15 and the one or more audio devices 16. Ofcourse, other interfaces or other connection mechanisms known to thoseskilled in the art may also be used to operatively connect theprocessing unit 15 to the one or more audio devices 16.

At least one of the electrode assembly 11 and processing unit 15 have atleast one processor that is configured to evaluate the cardiac conditionof the patient and cause delivery of the appropriate treatment to thepatient. The therapy pads 17 are configured to provide treatment, suchas, for example, electric defibrillation, to the wearer after theprocessing unit 15 determines that such treatment should be delivered tothe patient. The therapy pads 17 may include the application devicesdisclosed in U.S. Pat. No. 5,078,134, or other devices configured toprovide treatment to the patient.

The processing unit 15 may display one or more visuals identifying thepatient's condition or conditions based at least in part on one or moreconditions sensed by the electrodes 10 a, 10 b, 10 c, and 10 d. Aspeaker may be an audio device 16 that is used to communicate with thepatient or others located near the patient. The speaker or other audiodevice 16 may be housed within the processing unit 15 or be attached tothe processing unit 15 or another portion of the wearable defibrillatorsuch as, for example, the electrode assembly 11.

A microphone may also be an audio device 16 attached to the processingunit 15. The microphone may be configured to detect patient andenvironmental noise. One or more portions of the processing unit 15 canbe operatively connected to, or otherwise incorporate, voice recognitionsoftware so the processing unit 15 can determine, based on whether ornot it recognizes the voice of the wearer, whether an arrhythmiacondition exists that warrants delivery of treatment or if such deliveryshould be delayed. The processing unit 15 may also be operativelyconnected to memory or another storage device that stores informationsuch as, for example, the patient's voice signature so the processingunit 15 may identify a speaker's voice and determine when the patient isproviding audio input.

The processing unit 15 may include one or more processors that areconfigured to use a confidence algorithm to determine when treatmentshould be delivered. The confidence algorithm may base arrhythmiadetection on one or more inputs such as, but not limited to, dataobtained from sensing electrodes 10 a, 10 b, 10 c and 10 d, one or moreelectrocardiograms. (“ECGs”), response button responsiveness testresults, voice recognition responsiveness test results, etc. Preferably,the processing unit 15 is configured so that treatment is not deliveredunless the confidence algorithm determines that there is a 100%confidence that the patient is experiencing a life threateningarrhythmia.

The one or more audio devices 16 may be configured to identify whetherbackground noise exists. In the event no or little background noise issensed, the confidence in the detection can be increased. The processingunit 15 may also be configured to permit the delivery of treatment to beaccelerated if no background noise or little background noise isdetected by the one or more audio devices 16.

The processing unit 15 may be configured to delay a delivery oftreatment if a high level of background noise is identified becausesignificant background noise may reduce the quality of the data obtainedby the electrodes 10 a, 10 b, 10 c, or 10 d. For example, the quality ofECG sensing electrodes may be reduced with significant background noisepossibly caused by patient motion and can result in false detection of acondition requiring treatment. If a high level of background noise isidentified, the processing unit 15 can be configured to delay treatmentso other tests or data can be obtained to verify that the patientrequires treatment or to increase the audio output level of alarms usedto warn any people surrounding the patient that treatment is about to beprovided to the patient so that no one touches the patient during theapplication of the treatment.

The audio devices 16 may also be configured so that speaker volumes areincreased whenever certain background noise levels are detected. Suchincreased volumes permit audio outputs to be heard by the patient orpeople near the patient when the patient is in a high noise environment.Such audio outputs may include alarms, instructions or communicationrelated to patient responsiveness tests, which are discussed more fullybelow.

The processing unit 15 may be configured to cause a voice recognitionresponsiveness test to be run as part of determining that the patient isexperiencing a condition requiring treatment. The voice responsivenesstest may include an audio device 16, such as, for example, a speaker, toverbally ask the patient if the patient is conscious. In the event amicrophone or other audio device 16 senses that the patient respondswith a positive verbal comment, such as, for example, “yes”, theprocessing unit 15 can be configured to delay treatment. In the eventthe patient does not provide an answer that is sensed by an audio device16 or that such data is not provided to the processing unit 15, theprocessing unit 15 can be configured to cause a speaker to provide averbal message asking the patient to press one or more buttons oractivate one or more actuators connected to the defibrillator to verifythe patient is conscious. The one or more buttons may be located on, in,or adjacent the belt, harness, vest, or monitor of the defibrillator.

In one embodiment, the processing unit 15 can be configured to cause thespeaker to ask the patient certain questions in the event a possiblecondition is identified that may require delivery of a treatment. Forexample, the speaker may be configured to ask the patient “are youconscious?” or “if you are conscious, please state your name.” Theprocessing unit 15 can be operatively connected to memory or anotherstorage device that contains the patient's voice signature to verify thepatient is answering the questions. Such verification prevents apasserby from preventing treatment of the patient by improperlyresponding to the questions.

The use of audio devices 16, such as, for example, a microphone and aspeaker, permit the patient to have real-time input provided to thedefibrillator. The processing unit 15 may also be configured to recordthe audio input in the proximity of the wearable device for later reviewby emergency personnel. Such information may help care providersdetermine a diagnosis for the patient or treat the patient.

The one or more audio devices may also be operatively connected to theprocessing unit 15 such that the processing unit 15 can cause thepatient's conditions being sensed by electrodes 10 a, 10 b, 10 c, or 10d to be recorded and stored. Such recording and storage can be actuatedby verbal commands issued by the patient that are received by the audiodevice 16, such as, for example, a microphone, or by the actuation of anactuator such as, for example, a button operatively connected to theprocessing unit 15. The processing unit 15 can also be configured so theaudio device 16, such as, for example, a microphone, records a messageprovided by the patient that explains how he feels and why he initiatedthe recording of the conditions being sensed by one or more of theelectrodes 10 a, 10 b, 10 c, and 10 d. The recorded audio and sensedinformation may be stored in memory operatively connected to theprocessing unit 15 or be transmitted to a central location and/or tohealth care providers. Transmissions to a central location are discussedmore fully below. Such recordings may permit a health care provider ordoctor to formulate a diagnosis based on the sensed conditions orotherwise act on such information to provide services the recordedconditions indicate the patient needs.

In the event the patient has difficulty with an aspect of thedefibrillator, the processing unit 15 can be configured so a speaker orother audio device provides the patient with certain verbalinstructions. The instructions may also be provided in specificsituations where the patient has difficulty understanding instructionsor the processing unit 15 is not receiving any expected input from thepatient. Special messaging instructions can be recorded during patientsetup to support the personal communication needs of the patient or maybe operatively connected to the processing unit 15 such that theinstructions may be provided to the patient during the setup of thedefibrillator in the event the patient is having difficulty with thesetup. For example, such a special message may include contactinformation for customer support or a voice activated menu of differentlanguages the instructions may be given in that the patient may selectfrom.

Standard voice messages or alarms delivered prior to or during thedelivery of treatment may be customized for a patient. The standardalarms may also be modified so that a speaker or other audio deviceprovides audio output in a language the patient understands (e.g.,Spanish, English, French, German, etc.). Additionally, the messages maybe customized to include the name of the patient to personalize theinstructions.

The audio input and outputs provided by the defibrillator may be createdor modified during a setup phase conducted during an initial use of thedefibrillator by a patient. Such a setup phase may be used to determinethe language all audio output should be spoken in and permit the name ofthe patient to be learned by the processing unit or stored in memoryconnected to the processing unit. The processing unit 15 may also beconfigured so that the patient's voice signature is identified and savedin a storage device, such as, for example, memory in the processing unit15 or memory operatively connected to the processing unit 15.

The processing unit 15 can also be configured to generate a uniqueidentifier that is related to the patient. Such an identifier may beused to determine who the patient is or the patient that is assigned towear the defibrillator. Features from the patient's voice signature orsaved voice recordings can be used to create the identifier. Such anidentifier may be created as part of the setup phase.

Facilities that have multiple patients that are required to weardefibrillators may need a method of determining which patient isassigned to wear a particular defibrillator so the facility can ensurethe proper defibrillator is worn by the proper patient. A recording ofthe patient's name may be stored in memory contained within theprocessing unit 15, operatively connected to the processing unit 15 orotherwise stored by the processing unit 15. The name of the patient maythen be identified by an audio message sent by a speaker or other audiodevice 16 to identify the intended user of the device. The processingunit 15 may be configured so the audio device 16 provides such outputwhenever the device is activated or upon the activation of an actuatoroperatively connected to the processing unit 15, such as, for example, abutton on the monitor 15 or an actuator operatively connected to theprocessing unit 15. The processing unit 15 may also be configured so averbal command received from an audio device 16, such as, for example, amicrophone, may cause the patient's name to be output provided by anaudio device 16, such as, for example, a speaker.

Referring to FIG. 2, a wearable defibrillator 41 is typicallyincorporated into a system to provide treatment to a patient. The systemmay include a wearable defibrillator 41 that has a processor 33operatively connected to memory 34, a microphone 25, a speaker 24, oneor more therapy pads 17, one or more electrodes 10 and a base station 28that includes one or more networking or communication devices such as,for example, a modem or other networking device configured to connectthe processor 33 or defibrillator 41 to other devices such as, forexample, a computer or server or other central location 18. Theprocessor 33, memory 34, speaker 24 and microphone 25 may be housedwithin a processing unit 26 along with audio circuitry that includes,for example, a CODEC 23. In some embodiments, one or more communicationdevices such as, for example, a modem, network card, networkingprograms, other networking mechanisms or any combination thereof may beconnected to or incorporated into the processing unit 26 such that theprocessor 33 of the processing unit 26 is configured to cause one ormore of the communication devices to connect the wearable defibrillator41 to the central location 18. The central location 18 may include anapparatus operated by a hospital or other care monitoring entity that isconfigured to store patient related data transmitted to the centrallocation 18. The central location 18 may also be configured to overseeor manage at least a portion of the operation of one or more wearabledefibrillators 41.

The processor 33 may be configured so the patient may communicate withcustomer support personnel that are able to operatively connect to thecentral location 18. The patient may communicate with such personnelusing the microphone 25 and speaker 24. The base station 28 isoperatively connected with the processor 33 by a connection 20, whichmay be a wireless connection or a wired connection such as, for example,a USB connection. The base station 28 may include a wireless or wiredmodem or other transceiver that is preferably configured to establish alink 19 to the central location 18 that permits the microphone 25 tosend input received from the patient to the central location 18 so thatservice or support representatives may receive the information. Theprocessor 33, base station 28 and central location 18 are alsoconfigured so the speaker 24 may relay output obtained from the centrallocation 18. Such communications may be transmitted to and from thecentral location 18 by transceivers, modems or other devices operativelyconnected to the central location 18, base station 28 and/or processor33. The base station 28 or processing unit 26 may be configured toencrypt data transmitted to the central location 18 so that anyunsecured network (e.g., cellular, wireless, POTS, etc.) available to apatient can be used.

The communications obtained from the central location 18 may includefeedback from personnel connected to the central location 18. The basestation 28 and processor 33 may also be configured so the patient maycommunicate with emergency medical support personnel attempting to helpthe patient or to report problems with the defibrillator to medicalsupport staff or the manufacturer of the defibrillator. Such staff maybe connected to the central location 18 or may be available forcommunication through other means such as, for example, cellular phoneconnections or other communication apparatuses.

The central location 18 may include one or more computers, servers, andprograms or other software that are configured to send survey questionsor other queries to one or more patients. Such queries can includequestions regarding a patient's health or the condition of thedefibrillator. The processor 33 may also be configured so the speaker 24asks survey questions that are stored in the memory 34 so that periodicresponses from the patient can be recorded and stored in the memory 34,in the central location 18 or a device connected to the central location18. Such saved responses may be periodically updated and tracked toverify the patient is not experiencing any symptoms indicating increasedrisk of experiencing a condition that may require treatment. Changes inthe patient's voice may also be stored and tracked to determine changesin breathing characteristics as an additional symptom that may bepertinent to a change in the patient's condition or diagnosis.

Examples of survey questions or periodic condition status questions mayinclude: Are your legs swelling?; Are you having breathingdifficulties?; Have you experienced a gain in weight?; and Are yousitting up to sleep? Of course, various other questions relating tosymptoms of health conditions may also be used in addition to or inplace of such survey questions.

The microphone 25 and processor 33 can be configured to verify that thebase station 28 is connected to the central location 18 by recording amodem speaker audio or other audio that may be produced by the portionor device of the base station 28 that is configured to connect thedefibrillator 41 to the central location 18. The tones of the audioproduced by the base station 28 when trying to connect the defibrillator41 to the central location 18 can be analyzed by the processor 33 todetermine if the modem is attempting a connection. For instance, such ananalysis may be performed by comparing the audio input received by themicrophone 25 with tone data stored in the memory 34.

The microphone 25 may also be used to verify that certain internalcomponents are operating correctly by analyzing noise associated withactivation or deactivation of mechanical components of the wearabledefibrillator such as, for example, relays or switches. Correlation ofthe activation of the components with recorded audio may verify thefunctionality of the components.

For example, it can be predetermined that during a particular event,certain relays are activated at certain times. Such data can be storedin memory 34. The processor 33 can be configured to use amplitude andother audio input provided by the microphone 25 and time measurements toverify that the correct relays are activated at the correct times.

The processor 33 may be configured to cause a self-diagnostic test to berun whenever audio input is received that indicates the wearabledefibrillator 41 may have been damaged. Such audio input may includehigh amplitude and short duration noise. Such noise may be equivalent orsimilar to noise produced from an object such as, for example, a wall, afloor, a chair or a door banging against a portion of the wearabledefibrillator or when the defibrillator is dropped onto a hard surface.

The processor 33 may be configured to cause a system test to be run toverify that the wearable defibrillator 41 is functioning properly. Forexample, the processor 33 may cause an alarm to be emitted by thespeaker 24 at different frequencies and volumes and verify the alarm isbeing emitted at the different volumes and frequencies by comparing theexpected audio output of the speaker with the audio input received bythe microphone 25. If an alarm is found to not function properly, theprocessor 33 may be configured to operatively connect to the centrallocation 18 and report the problem to the central location 18 or toschedule servicing of the wearable defibrillator 41. The processor 33may operatively connect to the central location 18 by interacting withthe base station 28, as discussed above.

It should be appreciated that service personnel may review the resultsof the diagnostic tests and evaluate the results to determine if thewearable defibrillator needs servicing. While certain present preferredembodiments of the wearable defibrillator and certain embodiments ofmethods of practicing the same have been shown and described, it is tobe distinctly understood that the invention is not limited thereto butmay be otherwise variously embodied and practiced within the scope ofthe following claims.

What is claimed is:
 1. An external monitoring device comprising: atleast one sensor configured to be removably attached to a patient and tosense data indicative of a cardiac condition of the patient; an operatorinterface device; and at least one processor disposed in the externalmonitoring device, the at least one processor configured to allow forcustomization of information provided in at least one output message tobe delivered via the operator interface device; wherein the externalmonitoring device can be worn by the patient.
 2. The external monitoringdevice of claim 1, wherein the at least one output message comprises acustomized audio notification.
 3. The external monitoring device ofclaim 1, wherein the at least one output message comprises aninstruction to the patient.
 4. The external monitoring device of claim1, wherein the at least one output message can be customized by at leastone of the patient and a health care provider.
 5. The externalmonitoring device of claim 1, wherein the at least one output messagecomprises a customized alarm, and wherein the at least one processorcauses the operator interface device to provide the customized alarmupon detecting the cardiac condition of the patient.
 6. The externalmonitoring device of claim 5, wherein the at least one output messagecomprises an instruction to the patient to provide a response to thecustomized alarm, and wherein the at least one processor causes theoperator interface device to suspend the customized alarm upon receivingindication of the response from the patient.
 7. The external monitoringdevice of claim 1, wherein the at least one output message comprises acustomized alarm indicative of an issue concerning the externalmonitoring device other than the cardiac condition of the patient. 8.The external monitoring device of claim 1, wherein the at least oneoutput message comprises a customized alarm, one or more characteristicsof the customized alarm being adjustable by an operator.
 9. The externalmonitoring device of claim 8, wherein the customized alarm comprises oneor more of a tactile simulation alarm, a visual alarm, an audio alarm,and a voice alarm.
 10. The external monitoring device of claim 8,wherein the one or more characteristics comprises one or more of achange in a voice instruction provided as the customized alarm, afrequency of an audio signal emitted by the operator interface device asthe customized alarm, and a volume of the customized alarm.
 11. Theexternal monitoring device of claim 1, wherein the at least one outputmessage comprises a message addressing the patient by his or her name.12. The external monitoring device of claim 1, wherein the at least oneoutput message comprises a voice message provided in a language spokenby the patient.
 13. The external monitoring device of claim 12, whereinthe language of the voice message can be selected during setup of theexternal monitoring device for the patient.
 14. The external monitoringdevice of claim 1, wherein the at least one output message comprises amessage requesting a response from the patient.
 15. The externalmonitoring device of claim 14, wherein responsive to the patient notproviding the response, the at least one processor provides verbalinstructions to the patient via the operator interface device.
 16. Theexternal monitoring device of claim 1, comprising at least one responsebutton in communication with the at least one processor, wherein the atleast one output message comprises a notification to the patient to pushthe at least one response button.
 17. The external monitoring device ofclaim 1, comprising a memory in communication with the at least oneprocessor, wherein the at least one processor causes the memory to storethe at least one output message.
 18. The external monitoring device ofclaim 1, wherein the at least one processor is configured to allow forcustomization of the at least one output message at least in part byallowing an operator to perform the customization.
 19. The externalmonitoring device of claim 18, wherein the operator comprises one of thepatient and a health care provider.
 20. The external monitoring deviceof claim 1, wherein the at least one processor is configured to allowfor customization of the at least one output message at least in part byallowing for customization of the at least one output message during adevice setup phase.
 21. The external monitoring device of claim 1,comprising a communication device to communicate with at least one of acentral facility network and a health care provider network.
 22. Theexternal monitoring device of claim 1, wherein the at least one outputmessage comprises a survey question to the patient.
 23. The externalmonitoring device of claim 1, wherein the operator interface devicecomprises an audio input device, wherein the at least one processorcauses the audio input device to receive a spoken message.
 24. Theexternal monitoring device of claim 1, further comprising a wirelesscommunications device configured to communicate at least one of the dataindicative of the cardiac condition of the patient and the at least oneoutput message between the external monitoring device and at least oneof a health care provider, emergency medical support personnel, andcustomer support personnel.
 25. The external monitoring device of claim24, wherein the wireless communications device is configured tocommunicate with the at least one of the health care provider, theemergency medical support personnel, and the customer support personnelvia a base station.
 26. The external monitoring device of claim 24,wherein the wireless communications device is configured to send thedata indicative of the cardiac condition of the patient to the at leastone of the health care provider, the emergency medical supportpersonnel, and the customer support personnel.
 27. The externalmonitoring device of claim 24, wherein the wireless communicationsdevice is configured to receive the at least one output message from theat least one of the health care provider, the emergency medical supportpersonnel, and the customer support personnel.
 28. The externalmonitoring device of claim 1, wherein the at least one output messagecomprises a voice activated menu of different languages in whichinstructions can be provided, and wherein a language in which theinstructions are provided can be selected using the voice activatedmenu.
 29. The external monitoring device of claim 1, wherein the atleast one output message comprises a customized message recorded duringsetup of the external monitoring device for the patient.
 30. Theexternal monitoring device of claim 1, wherein the at least one outputmessage comprises at least one survey question regarding at least one ofa health of the patient and a condition of the external monitoringdevice.
 31. The external monitoring device of claim 1, wherein the atleast one output message comprises verbal instructions responsive to thepatient having difficulty understanding instructions.
 32. An externalmonitoring device comprising: at least one sensor configured to beremovably attached to a patient and to sense data indicative of acardiac condition of the patient; an operator interface device; and atleast one processor disposed in the external monitoring device, the atleast one processor configured to allow for customization of informationprovided in at least one output message to be delivered via the operatorinterface device; wherein the external monitoring device can be worn bythe patient; and wherein the external monitoring device can providetreatment relating to the cardiac condition to the patient.
 33. Theexternal monitoring device of claim 32, wherein the at least one outputmessage comprises a customized alarm, and wherein the at least oneprocessor causes the operator interface device to provide the customizedalarm upon providing the treatment relating to the cardiac condition.34. An external monitoring device comprising: at least one sensorconfigured to be removably attached to a patient and to sense cardiacdata relating to the patient; an operator interface device for providingone or more customized alarms upon detecting a cardiac condition in thecardiac data; and at least one processor configured to allow foradjusting one or more aspects of the one or more customized alarms;wherein the external monitoring device comprises a wearable monitoringdevice.
 35. The external monitoring device of claim 34, wherein thecardiac condition comprises an arrhythmia.
 36. The external monitoringdevice of claim 34, wherein the operator interface device comprises anaudio output device, and wherein the one or more aspects of the one ormore customized alarms that can be adjusted includes at least one of afrequency and an amplitude of the one or more customized alarms.
 37. Theexternal monitoring device of claim 36, wherein the operator interfacedevice further comprises one or more microphones, and wherein the atleast one of the frequency and the amplitude of the one or morecustomized alarms is adjusted based upon audio input received from theone or more microphones.
 38. The external monitoring device of claim 37,wherein the amplitude of the one or more customized alarms is increasedresponsive to the audio input received from the one or more microphonesindicating the external monitoring device is in a high noiseenvironment.